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TUR Y-set for Transurethral Resection and Cystoscopy Irrigation Set(2014-03-31)
- Starting date:
- March 31, 2014
- Posting date:
- June 5, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39771
Recalled products
- TUR Y- set for Transurethral Resection
- Cystoscopy Irrigation Set
Reason
The TYVEK cover (white lid) may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package. The opening in the packaging of the affected product provides the opportunity for infectious agents and particulates matter to enter into the irrigation system and be transferred into the urinary tract.
Affected products
A. TUR Y-set for Transurethral Resection
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 06543-XX
Companies
- Manufacturer
-
Hospira Inc.
275 North Field Drive
Lake Forest
60045
Illinois
UNITED STATES
B. Cystoscopy Irrigation Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 06544-XX
Companies
- Manufacturer
-
Hospira Inc.
275 North Field Drive
Lake Forest
60045
Illinois
UNITED STATES